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Weight LossNCT02627105

The Beef WISE Study: Beef's Role in Weight Improvement, Satisfaction, and Energy

A study testing Beef group and Non-beef group in people with Weight Loss, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a 6 month long study to evaluate the inclusion or exclusion of beef within a weight loss program. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Weight Loss
What is being tested?
Beef group and Non-beef group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
Sep 2015to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Males and females between 18 - 50 years old
  • BMI of 27 or greater
  • Weight stable (have not lost or gained more than 10 pounds in the last 3 months)
  • Generally healthy
  • Able to exercise 70 minutes per day at moderate intensity
  • Willing and able to participate in a weekly group class for the first 16 weeks of the study and willing to participate in 4 study visits over the 6 month study period

Who cannot join

  • Pregnant or trying to become pregnant.
  • Diagnosis of type 1 or type 2 diabetes
  • Individuals following a vegetarian/vegan only diet
  • Food allergies (to red meats or other common protein sources)
  • Taking medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over the counter weight loss agents). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Vitamins and minerals which do not have a weight effect are allowed as long as use is continued without change during the study.
  • Current Eating disorder (anorexia or bulimia)
Show all 11Show fewer
  • Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
  • Any medical condition for which following a high protein diet and/or 70 minutes of exercise daily would be inadvisable
  • LDL cholesterol levels above 160 mg/dl or triglycerides above 400 mg/dl.
  • Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least 3 months.
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Colorado Denver

    Aurora, Colorado, 80045

Other trials in United States

About this study

This is a 6 month long study to evaluate the inclusion or exclusion of beef within a weight loss program.

Read the detailed description

This study will compare two protein sources: proteins to include beef as the sole source of red meat compared to proteins excluding red meat within the context of an effective higher-protein weight loss and maintenance program derived from the Colorado Diet.

All subjects will participate in a group-based program consisting of 16 weekly classes in 3-phases designed to produce weight loss and teach participants how to achieve a lifestyle to keep weight off permanently. All groups will be closed (same subjects, same leader) and will consist of 20 participants. Participants in both groups will receive instruction in cooking, recipes, and shopping instruction (using our grocery laboratory). This training will include strategies, tips and preparation techniques for preparing high protein meals according to their assigned groups. All subjects are given exercise plans and all subjects will receive memberships to the Anschutz Health and Wellness Center fitness center for the duration of the study.

After completion of the 16-week program, subjects will be asked to follow the program on their own for an additional 2 months.

This is a randomized study involving 120 study subjects (60 per arm). The investigators will compare the efficacy of inducing weight loss of two treatment arms derived from the Colorado Diet. Subjects will be randomly assigned to one of two study arms and instructed to follow the higher-protein diet by participating in weekly group classes for the first four months of the study. There will be 6 classes of 20 subjects each (three classes for each treatment group). Subjects will be followed in the study for 6 months. Subjects will be randomized into one of two treatment groups as follows:

  • Group 1(SOS+B): Subjects will participate in a State of Slim group class, receive a State of Slim book (describing the Colorado Diet), and will receive stipends to be used to help purchase protein food items allowed in the Colorado Diet as modified. The Colorado diet is a high protein (estimated 120-160g/day), low carb and low fat diet. Subjects will be directed and instructed to include beef as their sole source of red meat as a protein source during the study. Subjects will follow the diet protein guidelines, but will be directed and instructed to consume 4 or more servings of beef per week and instructed not to consume any other red meats. Other red meats to be avoided include pork, veal, lamb, buffalo and venison. Subjects will be advised to use the monetary stipends to purchase items from the lists of acceptable foods from the SOS book (to include beef products). Processed beef items will be allowed as identified by a list provided to the subjects.
  • Group 2 (SOS): Subjects will participate in a State of Slim class, receive the State of Slim book (describing the Colorado Diet), and will receive stipends to be used to help purchase protein food items allowed in the Colorado diet as modified. Subjects will be directed and instructed to exclude beef and instructed not to consume any other red meats. Other red meats to be avoided include pork, veal, lamb, buffalo, and venison.
Conditions
Weight Loss
Being tested
Beef group, Non-beef group
Keywords
weight loss, red meats, obesity, lean body mass, body composition, dietary protein
Medical subject headings
Weight Loss, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beef groupBehavioural

    Subjects in the beef group will be asked to consume 4 or more servings of beef per week (and to avoid all other red meats) during the 6 month study.

  • Non-beef groupBehavioural

    Subjects in the non-beef group will be asked to avoid all red meats during the 6 month study.

Study groups in NCT02627105
Study groupRoleWhat they receive
Beef groupExperimentalSubjects in this group are asked to consume 4 or more servings of beef per week and to exclude all other red meats from their diet for the 6 month study.
Receives: Behavioral: Beef group
Non-beef groupOtherSubjects in this group are asked to avoid all red meats from their diet for the 6 month study.
Receives: Behavioral: Non-beef group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in % body weight at the end of a 16 week period and at the end of the 6 month period

    Measured: 16 weeks and 6 months

Secondary outcomes (6)
  1. Change from baseline in % body fat at the end of a 16 week period

    Measured: 16 weeks

  2. Change from baseline in lipid panel results at end of 16 week period and end of 6 month period

    Measured: 16 weeks and 6 months

  3. Change from baseline in fasting blood glucose results at end of 16 week period and end of 6 month period.

    Measured: 16 weeks and 6 months

  4. Change from baseline in hemoglobin A1C results at end of 16 week period and end of 6 month period.

    Measured: 16 weeks and 6 months

  5. Differences in responses to study questionnaires between the two groups regarding satisfaction with the weight loss program.

    Measured: 6 months

  6. Differences in responses to study questionnaires between the two groups regarding adherence to the weight loss program.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02627105
Sponsor's protocol ID
15-0989
Status last verified
Nov 2018
First submitted
3 Dec 2015
Last updated
8 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anderson GH, Moore SE. Dietary proteins in the regulation of food intake and body weight in humans. J Nutr. 2004 Apr;134(4):974S-9S. doi: 10.1093/jn/134.4.974S.

    PubMed 15051857
  • Anderson GH, Tecimer SN, Shah D, Zafar TA. Protein source, quantity, and time of consumption determine the effect of proteins on short-term food intake in young men. J Nutr. 2004 Nov;134(11):3011-5. doi: 10.1093/jn/134.11.3011.

    PubMed 15514267
  • Barkeling B, Rossner S, Bjorvell H. Effects of a high-protein meal (meat) and a high-carbohydrate meal (vegetarian) on satiety measured by automated computerized monitoring of subsequent food intake, motivation to eat and food preferences. Int J Obes. 1990 Sep;14(9):743-51.

    PubMed 2228407
  • Booth DA, Chase A, Campbell AT. Relative effectiveness of protein in the late stages of appetite suppression in man. Physiol Behav. 1970 Nov;5(11):1299-302. doi: 10.1016/0031-9384(70)90044-2. No abstract available.

    PubMed 5524514
  • Bowen J, Noakes M, Clifton PM. Appetite regulatory hormone responses to various dietary proteins differ by body mass index status despite similar reductions in ad libitum energy intake. J Clin Endocrinol Metab. 2006 Aug;91(8):2913-9. doi: 10.1210/jc.2006-0609. Epub 2006 May 30.

    PubMed 16735482
  • Foster GD, Wyatt HR, Hill JO, McGuckin BG, Brill C, Mohammed BS, Szapary PO, Rader DJ, Edman JS, Klein S. A randomized trial of a low-carbohydrate diet for obesity. N Engl J Med. 2003 May 22;348(21):2082-90. doi: 10.1056/NEJMoa022207.

    PubMed 12761365
  • Latner JD, Schwartz M. The effects of a high-carbohydrate, high-protein or balanced lunch upon later food intake and hunger ratings. Appetite. 1999 Aug;33(1):119-28. doi: 10.1006/appe.1999.0237.

    PubMed 10447984
  • Donnelly JE, Hill JO, Jacobsen DJ, Potteiger J, Sullivan DK, Johnson SL, Heelan K, Hise M, Fennessey PV, Sonko B, Sharp T, Jakicic JM, Blair SN, Tran ZV, Mayo M, Gibson C, Washburn RA. Effects of a 16-month randomized controlled exercise trial on body weight and composition in young, overweight men and women: the Midwest Exercise Trial. Arch Intern Med. 2003 Jun 9;163(11):1343-50. doi: 10.1001/archinte.163.11.1343.

    PubMed 12796071
  • Hill, J. H. & Blundell, J. E. (1986) Macronutrients and satiety: The effects of a high-protein or high-carbohydrate meal on subjective motivation to eat and food preferences. Nutr. Behav. 3: 133-144.

  • Marmonier C, Chapelot D, Louis-Sylvestre J. Effects of macronutrient content and energy density of snacks consumed in a satiety state on the onset of the next meal. Appetite. 2000 Apr;34(2):161-8. doi: 10.1006/appe.1999.0302.

    PubMed 10744905
  • Paddon-Jones D, Westman E, Mattes RD, Wolfe RR, Astrup A, Westerterp-Plantenga M. Protein, weight management, and satiety. Am J Clin Nutr. 2008 May;87(5):1558S-1561S. doi: 10.1093/ajcn/87.5.1558S.

    PubMed 18469287
  • Peters, J.C. Control of Energy Balance. In: Biochemical, physiological, molecular aspects of human nutrition. Second edition, M.H. Stipanuk ed. Saunders Elsevier, 2006, pp. 618-639.

  • Porrini M, Santangelo A, Crovetti R, Riso P, Testolin G, Blundell JE. Weight, protein, fat, and timing of preloads affect food intake. Physiol Behav. 1997 Sep;62(3):563-70. doi: 10.1016/s0031-9384(97)00162-5.

    PubMed 9272665
  • Rolls BJ, Hetherington M, Burley VJ. The specificity of satiety: the influence of foods of different macronutrient content on the development of satiety. Physiol Behav. 1988;43(2):145-53. doi: 10.1016/0031-9384(88)90230-2.

    PubMed 3212049
  • Veldhorst MA, Nieuwenhuizen AG, Hochstenbach-Waelen A, van Vught AJ, Westerterp KR, Engelen MP, Brummer RJ, Deutz NE, Westerterp-Plantenga MS. Dose-dependent satiating effect of whey relative to casein or soy. Physiol Behav. 2009 Mar 23;96(4-5):675-82. doi: 10.1016/j.physbeh.2009.01.004.

    PubMed 19385022

Questions about this trial

What is this clinical trial studying?

A study testing Beef group and Non-beef group in people with Weight Loss, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in % body weight at the end of a 16 week period and at the end of the 6 month period (time frame: 16 weeks and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02627105, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.

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